PharmaNest Inc. announced today a multi-institutional research collaboration with Virginia Commonwealth University (VCU) and the National Institutes of Health (NIH) to confirm the prognostic performance of artificial intelligence (AI) powered digital pathology biomarkers in metabolic dysfunction-associated steatotic liver disease (MASLD) in a retrospective cohort of 1,765 patients with MASH (NASH CRN DB2 Cohort)
PRINCETON, NJ / ACCESS Newswire / September 11, 2025 / PharmaNest Inc. announced today a multi-institutional research collaboration with Virginia Commonwealth University (VCU) and the National Institutes of Health (NIH) to confirm the prognostic performance of artificial intelligence (AI) powered digital pathology biomarkers in metabolic dysfunction-associated steatotic liver disease (MASLD) in a retrospective cohort of 1,765 patients with MASH (NASH CRN DB2 Cohort).
FibroNest derives a continuous biomarker of fibrosis severity through analysis of conventional digital pathology images at the fiber-level
The collaboration unites Professor Arun Sanyal, M.D. (Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at VCU), Dr. David Kleiner, M.D., Ph.D. (Principal Investigator, NIH NASH CRN), and Dr. Mathieu Petitjean, Ph.D. (CEO, PharmaNest). Together they will lead the Digital Pathology and AI for Liver Outcomes Study - 2 (DPAILO-2, NCT06493253), an NIH NASH CRN supported ancillary study.
Study Highlights:
Primary Objective: Evaluate the prognostic value of PharmaNest's FibroNest Ph-FCS biomarker, a high-resolution single-fiber AI-driven fibrosis continuous score, in predicting hepatic decompensation.
Comparative Goals: Compare Ph-FCS against conventional fibrosis staging and some non-invasive tests.
Exploratory Aims: Use single-fiber clustering (FibroMAP) on paired biopsies to uncover novel fibrosis risk phenotypes.
The study uses 1,765 anonymized digital pathology liver biopsies from the NAFLD Adult Database 2, stained with Masson's Trichrome and scanned at ultra-high resolution. PharmaNest will process the images and generate biomarkers on an accelerated basis to ensure timely results, which will be integrated into a secure VCU-hosted database for statistical analysis.
VCU will oversee governance, NIH compliance, and statistical analyses.
PharmaNest will sponsor, analyze images, and deliver AI-derived biomarkers within the 2025 timeline.
NIH's NASH CRN will provide clinical oversight and ensure alignment with network standards.
"This collaboration represents an important step toward establishing robust histological biomarkers that can guide patient management and accelerate drug development in MASLD," said Professor Arun Sanyal, M.D. Principal investigator.
"By combining the depth of NASH CRN's clinical expertise with PharmaNest's AI-powered single-fiber pathology and continuous fibrosis scores, we aim to accurately and quantitatively assess fibrosis progress and treatment response, and so provide better information for hepatologists and their patients," said Dr. David Kleiner, M.D., Ph.D., NIH's NASH CRN Liaison.
"PharmaNest is proud to bring its FibroNest Digital Pathology platform to this partnership. This landmark study will validate the strong prognostic power of our continuous biomarker Ph-FCS-already proven in over 400 patients with more than 10 years of follow-up-paving the way for regulatory-grade digital biomarkers in liver disease and unlocking new discoveries with our FibroMAP spatial histology tools." said Dr. Mathieu Petitjean, Ph.D. CEO at PharmaNest.
About the Partners
The Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University (VCU) is dedicated to advancing research, clinical care, and education to improve the prevention, diagnosis, and treatment of liver and metabolic diseases, fostering innovation and collaboration to reduce the global burden of these conditions.
NASH Clinical Research Network (NASH CRN) is an NIH-funded collaborative network advancing research in nonalcoholic fatty liver disease and steatohepatitis.
PharmaNest Inc. is a digital pathology company pioneering AI-driven single-fiber analysis for fibrosis and inflammation in preclinical and clinical studies.
Contact Information
Mathieu Petitjean
CEO
info@pharmanest.com
(609) 375 2003
SOURCE: PHARMANEST
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/pharmanest-nih-and-vcu-launch-confirmatory-retrospective-outcome-study-with-1-765-pat-1071811
